Setting Up and Overseeing Mass Spectrometry-Based Labs in Physician Offices and Other Non-Traditional Sites (PMSI)
Marion L. Snyder, Emily L. Ryan
2017
The Journal of Applied Laboratory Medicine
In recent years, mass spectrometry-based testing has increasingly been adopted by physician office laboratories (POLs) 3 and smaller laboratories. Physician groups, particularly pain management practices, are insourcing this technology owing to increased need for medication monitoring for patients treated with chronic opioid therapy and the associated testing revenue (1). Drug testing in the POL setting has historically been limited to pointof-care screening and/or immunoassay analyzerbased
more »
... ening, both of which have known accuracy limitations (2). Although mass spectrometry-based drug testing, coupled with either liquid or gas chromatography, provides a more accurate and comprehensive view of patient's medication and illicit drug use, the technology has intricacies beyond typical FDA-approved platforms. This reflection aims to highlight some of the challenges faced when implementing mass spectrometry in a physician office setting. Introducing mass spectrometry testing in a clinical laboratory involves more extensive planning than typical POL platforms in terms of space, electrical, gas supply, ventilation, and computer connections. POLs are usually constructed in existing clinic office space and housed in an interior room, making it difficult to maintain appropriate temperature control. Space constraints and heat dissipation are frequently an issue in these smaller laboratories, as is exhaust ventilation. Many laboratories struggle to obtain sufficient electrical supply for the mass spectrometer and/or nitrogen generator. Not all mass spectrometers are equal in terms of electrical, heat, and gas requirements; these factors must be considered when matching instrumentation with the available laboratory space. Procurement of the specific supplies needed for mass spectrometry laboratories is also frequently challenging for POLs. Multiple different vendors for instrumentation, analytical standards, solvents/consumables, extraction equipment, and basic laboratory supplies are generally required and establishing these vendor relationships can be cumbersome. Although experienced laboratorians recognize that laboratory supplies are frequently not interchangeable (i.e., sample extraction supplies/reagents are vendor-specific; not all 2-mL glass vials are alike; ACS-grade methanol is not equivalent to LC-MS grade), clinic management/ purchasing departments are unaccustomed to these nuances and may attempt substitutions when faced with a bill for a few thousand dollars for solvents, for example. The ongoing pressures to minimize costs can degrade testing quality and consistency if laboratory management is not included in the purchasing decisions.
doi:10.1373/jalm.2017.023473
pmid:33636895
fatcat:qkphxpyuhbdzxk2uyg6xtsqyay